The company I work for develops software that supports cardiology care. Thus far we have deliberately stayed in the lowest-risk class of applications, which...
... (snip) ... As a long-time software QA project lead who has spent the last 10 years in the FDA arena, I have both some experience with, and stories about,...
Mike, Thank you for your helpful reply. It fits with what we know already and with some advice I've had from Scott. I am particularly interested in your...
... Rod, You might want to consider posting this message to the Extreme Programming group as well as here. There are several people there who have applied...
You may also want to try the Agile PM group. I know there are several folks over there -- Glen Alleman in particular -- that have experience in regulated...
I was going through the glossary at http://www.agilemodeling.com/essays/glossary.htm <http://www.agilemodeling.com/essays/glossary.htm> and found the ...
(responding to Steve, Rod) ... I have a couple of old 'names' of folk that used to talk on the topic - these date back over 2 years ago, the people may have...
(responding to Prabhakar) ... The definition originally was made, if I recall correctly, to bring home the point that a developer is a lot more than a coder. ...
On 2 May 2006, at 08:19, Prabhakar Karve wrote: [snip] ... [snip] Personally I'd want every developer to have that knowledge and have those goals. Some might...
Adrian Howard
adrianh@...
May 2, 2006 12:04 pm
4148
... I've recently given talks to QA/Test groups specifically on the role of QA and testing professionals in agile development. See ...
Rod, ... the ... task. I agree that Scott's AUP is the key. I was using a similar, home- grown approach before I found his site and have accelerated our move ...
... in ... As do I - AUP was what I had proposed to implement when given the opportunity to do so in a regulated environment. ... any ... of ... The problem...
... Share http://www.agilemodeling.com/essays/examiningBRUF.htm with them next time they mention this concept. At least you'll have fun watching their heads...
... I thought the point was that the regulations lead to good ass-covering. Not really a joke; I think the point of much of this kind of behaviour is to be...
... Ahhhh.... that's where I got confused. ;-) ... Yes, I've seen that a fair bit in organizations where FDA compliancy, or even Sarbox, is a concern. My...
Well, if you're building a product that could be the subject of enormous liability suits, "cover your ass" is pretty important. If those "outsiders who may not...
At 03:26 PM 5/2/2006, Scott P. wrote: <snip> ... Actually, all of the studies that I've ever seen show that companies at level N do better than those at level...
... Despite the slightly snarky tone of my original post I don't disagree with you at all. I think the original objection people had was to the creation of ...
... Having worked in several regulated situations which were life critical, I've invariably found that most people did care a great deal about ensuring that...
... I'm not so sure I fully agree. What I've seen: 1. Many docs were cleaned up at the very end of the project. 2. Some docs that "should" have been created...
I guess the problem is distinguishing the CYA from the stuff that companies do because they believe they will improve their work. The things that were...
... The problem that I've seen is that many people think the extra documentation does help things, yet it doesn't seem to. I had an interesting conversation...
... Yes, but [at least in an environment as large and complicated as the one I'm most familiar with] the document is the way the affected parties get to...
From: "Scott W. Ambler" <swa@...> Sent: Tuesday, May 02, 2006 4:20 PM ... Of course it's the VALUE perceived by stakeholders and developers in having ...
John Hanna
j.hanna@...
May 2, 2006 9:42 pm
4163
... But just barely good enough is in the eye of the beholder. If you're not confident, then it mustn't be good enough and therefore you should invest more in...
At 05:49 PM 5/2/2006, you wrote: <snip> ... Imagine that we keep agile software development methods in the realm of software and not worry about potentially...
Hello all, I've been in meetings most of the day, and I am just now digesting all your thoughtful and insightful messages. I will reply a bit later on several...
I just started an engagement in Calgary and I think there is a fairly active agile presence here. I thought there was a thing called the "Calgary Agile Methods...
software is like rope manufacturing? to a mountain climber... we get pretty picky about our rope. barely good enough doesn't cut it. we want it to meet safety...
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